At a glance
ClinicalIndex Comparison Record- ✓Recipients of allogeneic bone marrow, cord blood, or peripheral blood stem cell transplants
- ✓Age >6 years and able to complete pulmonary function testing
- ✓Evidence of sub-acute, non-infectious pulmonary dysfunction (OLD or RLD)
- ✓Greater than 100 days post-transplant
- ✕Positive quantitative bacterial culture from BAL fluid (≥10⁴ CFU/ml)
- ✕BAL fluid positive for significant bacterial pathogens or pathogenic nonbacterial microorganisms by special stain, culture, or PCR
- ✕CMV seropositivity at study entry
- ✕Hypotension requiring inotropic agents other than dopamine <5 mcg/kg/min
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Sub-Acute Pulmonary Dysfunction Following Allogeneic Stem Cell Transplantation. A Phase II Study
In Brief
A Phase 2 clinical trial evaluating Etanercept for Lung Injury, Acute and 2 related conditions. Completed, enrolled 34 participants across 1 site.
Detailed Summary
The purpose of this study is to determine the effectiveness of etanercept in the treatment of patients with sub-acute lung injury following a bone marrow transplant. This study will also examine the toxicity of treatment with etanercept as well as whether there is an improved quality of life in these patients.
Study Details
Timeline
Interventions
Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages.